Revisiting Prior Cancer as an Exclusion Criterion for Cancer Clinical Trials

重新审视既往癌症作为癌症临床试验的排除标准

基本信息

批准号：
10463676
负责人：
Sandi Leigh Pruitt
金额：
$ 64.79万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-14 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10463676
关键词：
Accounting Adult Advocate Affect Age American College of Radiology Imaging Network Belief Breast Cancer Patient Cancer Survivor Characteristics Clinical Trials Clinical Trials Design Colorectal Colorectal Cancer Data Diagnosis Eastern Cooperative Oncology Group Eligibility Determination Enrollment Epidemiologic Methods Exclusion Exclusion Criteria Face Frequencies Health Information Dissemination Infrastructure Kidney Knowledge Lead Link Liver Malignant Neoplasms Malignant neoplasm of lung Malignant neoplasm of pancreas Medicare National Cancer Institute National Clinical Trials Network Newly Diagnosed Non-Hodgkin&apos s Lymphoma Outcome Pancreas Patients Persons Policies Population Prevalence Protocols documentation Recording of previous events Research Research Personnel Risk SEER Program Stage at Diagnosis Statistical Methods Time Translating Work base cancer care cancer clinical trial cancer diagnosis cancer type care delivery care outcomes cohort evidence base health care service utilization human old age (65+)improved malignant breast neoplasm member mortality mortality risk novel older patient population based public health relevance sociodemographics systematic review

项目摘要

Project Description (abstract) Despite intensive efforts to increase participation, fewer than two percent of US adults are enrolled in clinical trials. More than 40% of National Cancer Institute (NCI)-sponsored trials fail to complete accrual. Clinical trial eligibility criteria present one of the most significant barriers to study accrual and one of the few accrual factors directly controlled by investigators and sponsors. Prior cancer is a widespread exclusion criterion in cancer trials. Our study will provide novel evidence required to objectively reconsider the exclusion of cancer survivors with newly diagnosed (incident) cancer from cancer clinical trials. Specifically, in two aims, we will 1) systematically review how this criterion is incorporated in NCI-sponsored trial protocols and 2) evaluate the impact of prior cancer on cause-specific and all-cause mortality for older patients with six common and deadly cancers: breast, colorectal, kidney, liver, Non-Hodgkin’s lymphoma, and pancreas. We will conduct these analyses using sophisticated epidemiologic and statistical methods applied to high-quality, population-based SEER-Medicare data. We will quickly disseminate findings via our External Advisory Board comprised of national leaders in clinical trials and patient advocates. The potential impact of this work to change research and practice is enormous. More than one third of all people diagnosed with cancer in the US are diagnosed with one of the six cancer types in this proposal; and of these, an estimated 13.5% of those over age 65 years have a prior cancer history and thus are at risk of systematic exclusion from cancer trials.

项目描述（摘要）尽管大力努力增加参与，但我们成年人中只有不到2％的人参加了临床试验。超过40％的国家癌症研究所（NCI）赞助的试验未能完成。临床试验资格标准是研究准确性的最重要障碍之一，也是少数准确性之一由调查员和赞助商直接控制的因素。先前的癌症是宽度的排除标准癌症试验。我们的研究将提供客观地重新考虑癌症排除所需的新证据来自癌症临床试验的新诊断（入口）癌症的幸存者。具体来说，在两个目标中，我们将 1）系统地检查如何将此标准纳入NCI赞助的试验方案，2）评估先前癌症对六名常见和致命的老年患者的因素特异性和全因死亡率的影响癌症：乳腺癌，结直肠，肾脏，肝脏，非霍奇金淋巴瘤和胰腺。我们将进行这些使用精致的流行病学和统计方法的分析应用于高质量的基于人群 SEER-MEDICARE数据。我们将通过包括的外部顾问委员会迅速传播调查结果临床试验和患者拥护者的国家领导者。这项工作对改变研究的潜在影响实践是巨大的。在美国被诊断出患有癌症的所有患者中，有超过三分之一被诊断出该提案中的六种癌症类型之一；其中，估计65岁以上的人中有13.5％具有先前的癌症史，因此有系统地排除癌症试验的风险。